This study describes the Osseointegration Group of Australia’s
Accelerated Protocol two-stage strategy (OGAAP-1) for the osseointegrated
reconstruction of amputated limbs. We report clinical outcomes in 50 unilateral trans-femoral amputees
with a mean age of 49.4 years (24 to 73), with a minimum one-year
follow-up. Outcome measures included the Questionnaire for persons
with a Trans-Femoral Amputation, the health assessment questionnaire
Short-Form-36 Health Survey, the Amputation Mobility Predictor scores
presented as K-levels, 6 Minute Walk Test and timed up and go tests.
Adverse events included soft-tissue problems, infection, fractures
and failure of the implant.Aims
Patients and Methods
Internal lengthening devices in the femur lengthen
along the anatomical axis, potentially creating lateral shift of
the mechanical axis. We aimed to determine whether femoral lengthening
along the anatomical axis has an inadvertent effect on lower limb
alignment. Isolated femoral lengthening using the Intramedullary
Skeletal Kinetic Distractor was performed in 27 femora in 24 patients
(mean age 32 years (16 to 57)). Patients who underwent simultaneous realignment
procedures or concurrent tibial lengthening, or who developed mal-
or nonunion, were excluded. Pre-operative and six-month post-operative
radiographs were used to measure lower limb alignment. The mean lengthening
achieved was 4.4 cm (1.5 to 8.0). In 26 of 27 limbs, the mechanical
axis shifted laterally by a mean of 1.0 mm/cm of lengthening (0
to 3.5). In one femur that was initially in varus, a 3 mm medial
shift occurred during a lengthening of 2.2 cm. In a normally aligned limb, intramedullary lengthening along
the anatomical axis of the femur results in a lateral shift of the
mechanical axis by approximately 1 mm for each 1 cm of lengthening.
We investigated the fracture-free survival of long bones stabilised by a telescopic intramedullary rod (TIMR) in patients with osteogenesis imperfecta with respect to the remodelling status of fracture or osteotomy sites and TIMR regions, in order to identify risk factors for fracture. A total of 44 femora and 28 tibiae in 25 patients with a mean age of 5.0 years (1.9 to 10.5) at presentation were studied. There were six patients with Sillence type I, five with type III, 13 with type IV and one with type V osteogenesis imperfecta. All received bisphosphonate treatment at the same stage during the mean follow-up of 7.3 years (0.5 to 18.1). The fracture-free survival was estimated at 6.2 years (95% confidence interval 5.1 to 7.3) by Kaplan-Meier analysis. More than half the fracture or osteotomy sites remained in a less-remodelled state at the latest follow-up or time of fracture. Of the 33 fractures, 29 (87.9%) occurred in long bones containing a less-remodelled site, and these fractures were located at this site. The relative fracture risk at the rod tip was significantly greater than in any other TIMR region (p <
0.001), and this was higher in bone segments having a less-remodelled site. This study shows a persistent fracture risk in TIMR-stabilised long bones, especially at less-remodelled fracture or osteotomy sites and at the rod tip.